Otc - Active Ingredient
Avobenzone 2.5%
Homosalate 10%
Octisalate 5%
Bbw Spf 35 Pink Dream Lip Balm Stick
FDA Label NDC 51514-0367
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Autumn Harp for the product Bbw Spf 35 Pink Dream Lip Balm (NDC 51514-0367). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, dosage & administration, warnings, instructions for use, other safety information, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Avobenzone - Sunscreen
Homosalate - Sunscreen
Octisalate - Sunscreen
Dosage & 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.
Otc - Questions
1-800-395-1001
Indications & 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
Otc - 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.
* Please review the disclaimer below.
