Drug labels

BBW SPF 35 Natural Lip Balm, BBW SPF 35 Berry Lip Balm +1

BBW SPF 35 NATURAL LIP BALM, BBW SPF 35 BERRY LIP BALM +1 · Autumn Harp · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
0f8b024c-c481-951b-e063-6394a90ac63c
ID
0f8b024c-c482-951b-e063-6394a90ac63c
Effective time
20240122
Version
1
SPL product data elements

BBW SPF 35 Pink Dream Lip Balm BBW SPF 35 Pink Dream Lip Balm YELLOW WAX SUNFLOWER OIL HYDROGENATED COCO-GLYCERIDES LAUROYL LYSINE BENZYL ALCOHOL HOMOSALATE HOMOSALATE CASTOR OIL BUTYLOCTYL SALICYLATE MICA SOYBEAN OIL OCTISALATE OCTISALATE CANDELILLA WAX SHEA BUTTER COCOA BUTTER GARCINIA INDICA SEED BUTTER MEADOWFOAM SEED OIL .ALPHA.-TOCOPHEROL, DL- BENZYL SALICYLATE CARNAUBA WAX BENZYL BENZOATE STEVIA REBAUDIUNA LEAF ANISE OIL AVOBENZONE AVOBENZONE COCONUT OIL TITANIUM DIOXIDE FERRIC OXIDE RED FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW BBW SPF 35 Berry Lip Balm BBW SPF 35 Berry Lip Balm FD&C YELLOW NO. 5 ALUMINUM LAKE YELLOW WAX SUNFLOWER OIL HYDROGENATED COCO-GLYCERIDES LAUROYL LYSINE BENZYL ALCOHOL HOMOSALATE HOMOSALATE CASTOR OIL BUTYLOCTYL SALICYLATE MICA SOYBEAN OIL OCTISALATE OCTISALATE CANDELILLA WAX SHEA BUTTER COCOA BUTTER GARCINIA INDICA SEED BUTTER MEADOWFOAM SEED OIL .ALPHA.-TOCOPHEROL, DL- BENZYL SALICYLATE CARNAUBA WAX BENZYL BENZOATE STEVIA REBAUDIUNA LEAF ANISE OIL AVOBENZONE AVOBENZONE COCONUT OIL TITANIUM DIOXIDE D&C RED NO. 33 BBW SPF 35 Natural Lip Balm BBW SPF 35 Natural Lip Balm YELLOW WAX SUNFLOWER OIL HYDROGENATED COCO-GLYCERIDES LAUROYL LYSINE BENZYL ALCOHOL HOMOSALATE HOMOSALATE CASTOR OIL BUTYLOCTYL SALICYLATE MICA SOYBEAN OIL OCTISALATE OCTISALATE CANDELILLA WAX SHEA BUTTER COCOA BUTTER GARCINIA INDICA SEED BUTTER MEADOWFOAM SEED OIL .ALPHA.-TOCOPHEROL, DL- BENZYL SALICYLATE CARNAUBA WAX BENZYL BENZOATE STEVIA REBAUDIUNA LEAF ANISE OIL AVOBENZONE AVOBENZONE COCONUT OIL

Active ingredient
Avobenzone 2.5% Homosalate 10% Octisalate 5%
Purpose
Avobenzone - Sunscreen Homosalate - Sunscreen Octisalate - Sunscreen
Dosage and administration
Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating Immediately after towel drying at least every 2 hours
Warnings

For external use only Do not use on domaged or broken skin When using this product, keep out of eyes. Rinse with water to remove Sop use and ask a doctor if rash occurs

Instructions for use
Protect the product in this container from excessive heat and direct sun
Other safety information
Limit time in the sun, especially from 10am - 2pm Wear long sleeved shirts, pants, hats and sunglasses Children under 6 months of age: ask a doctor
Inactive ingredient

Natural Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate. Berry Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Red 33 Lake (CI 17200), Red 7 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate. Summer Crush Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Beeswax, Ricinus Communis (Castor) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Titanium Dioxide (CI 77891), Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Iron Oxide (CI 77492), Iron Oxides (CI 77491), Red 7 Lake (CI 15850), Tocopherol, Iron Oxides (CI77499), Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

Questions
1-800-395-1001
Indications and usage

Helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Keep out of reach of children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Package label principal display panel
Summer dream drug facts box Berry drug facts box Natural drug facts box
Harmonized identifiers (openFDA)
Application number
M020
Brand name
BBW SPF 35 Natural Lip Balm, BBW SPF 35 Berry Lip Balm, BBW SPF 35 Pink Dream Lip Balm
Generic name
BBW SPF 35 NATURAL LIP BALM, BBW SPF 35 BERRY LIP BALM, BBW SPF 35 PINK DREAM LIP BALM
Manufacturer name
Autumn Harp
Product NDC
51514-0365, 51514-0367, 51514-0366
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
HOMOSALATE, OCTISALATE, AVOBENZONE
SPL ID
0f8b024c-c482-951b-e063-6394a90ac63c
SPL set ID
0f8b024c-c481-951b-e063-6394a90ac63c
Package NDC
51514-0367-1, 51514-0366-1, 51514-0365-1
Is original packager
true
UNII
G63QQF2NOX, 4X49Y0596W, V06SV4M95S
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.