Acaifusion Lip Balm Broad Spectrum Spf 30
FDA Label NDC 75936-118

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Supergoop Llc for the product Acaifusion Lip Balm Broad Spectrum Spf 30 (NDC 75936-118). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients                                                    Purpose

Avobezone 3%, Octinoxate 7.5%, Octisalate 5%     Sunscreen

Otc - Purpose

Uses

-Helps prevent and temporarily chafed,chapped, cracked, or windburned skin and/or lips.
-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 product is swallowed, get medical help or
contact a Poison Control Center right away.

Indications & Usage

· Stop use and ask a doctor if rash occurs

Warnings

Warnings

· For external use only
· Do not use on damaged or broken skin
· When using this product keep out of eyes. Rinse with water to remove.

Dosage & Administration

Directions


- Apply liberally 15 minutes before sun exposure
- Reapply Liberally as often as necessary.
- Sun Protection Measures. Spending time in the sun increases your risk of skin
cancer and early skin aging. To decrease this risk, regularly use a sunscreen
with broad spectrum SPF of 15 or higher and other sun protection measures
including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating

Inactive Ingredient

Inactive Ingredients-Petrolatum, Ozokerite, Beeswax, Polyester-7, Neopentyl Glycol Diheptanoate, Flavor, Sorbitan Oleate, Euphorbia Cerifera (Candelilla) Wax, Polysilicone-15, Glycine Soja (Soybean) Oil, Tocopherol, Butyrospermum Parkii (Shea) Butter, Honey, Ascorbyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Ricinus Communis (Castor) Seed Oil, Red 27 Lake, Cocos Nucifera (Coconut) Fruit Extract

Package Label.Principal Display Panel

Doctor T's Supergoop

SPF 30

Acaifusion Lip Balm

with Shea butter

Broad Spectrum SPF 30

.5 fl. oz. / 15 ml

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