Label: BELLA PELLE SPF 30 - octinoxate, zinc oxide lotion
- NDC Code(s): 59663-140-04
- Packager: Shine & Pretty (USA), Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated July 9, 2013
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- Active Ingredients
Octinoxate, 7.5% (UVB sunscreen), Zinc oxide, 10.0% (UVA/UVB sunscreen)Close
For external use only, not to be swallowed. Avoid contact with eye. Discontinue if signs of irritation or rash appear.Close
For Sun protection for surfaces of skin, face, arm and hand. SPF-15 provides the face and body skin with effective protection against harmful UVA and UVB rays. Use daily over moisture cream to help prevent premature aging and wrinkling due to prolonged exposure to the sun, reapply after swimming or excessive exercise.Close
Paraben and PABA free.
Fairly water resistant.
Not tested on animals.
Made in the USA specifically for professional dermatology and esthetic practices.
- Directions for Use
Home Care: Apply SPF 30 liberally to face and body at least ten minutes before sun exposure or two minutes before applying makeup. Reapply after swimming or excessive perspiration. As part of effective age-fighting program, apply every morning throughout the year. Because SPF 30 is a blend of UV absorbing and reflecting sunscreens, it may be applied over or under moisturizer.Close
Facial Procedure: SPF 30 is recommended as the finishing product at the end of the facial procedure for any skin type. It may be applied over finishing cream or moisturizer. It should not be rubbed in completely, but left on the skin until it becomes transparent.
- Inactive Ingredients
Water, ethylhexyl palmitate, cyclomethicone, laurylmethicone, butylene glycol, tocopheryl acetate, sodium chloride, kukui (aleurites moluccana) seed oil (lipid-rich plant oil), green tea (camellia oleifera) seed extract, aloe vera (aloe barbadensis) leaf extract, tetrahexyldecyl ascorbate (time-released age-fighting vitamin C), allantoin, sodium PCA (hydrating), disodium EDTA, ethylhexylglycerin, methylisothiazolinone, fragrance (synthetic citrus).Close
- Keep out of the reach of children
Keep Out of the reach of children. Use on children under six months of age only with the advice of a physician.Close
- Principal Panel Display
- INGREDIENTS AND APPEARANCE
BELLA PELLE SPF 30
octinoxate, zinc oxide lotion
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59663-140 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) CHAMOMILE (UNII: FGL3685T2X) CUCUMBER (UNII: YY7C30VXJT) ETHYLHEXYL PALMITATE (UNII: 2865993309) CYCLOMETHICONE (UNII: NMQ347994Z) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM CHLORIDE (UNII: 451W47IQ8X) KUKUI NUT (UNII: J87WJ3E7VW) CAMELLIA OLEIFERA SEED (UNII: 59ED29FM2J) ALOE VERA LEAF (UNII: ZY81Z83H0X) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) ALLANTOIN (UNII: 344S277G0Z) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59663-140-04 120 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2013 Labeler - Shine & Pretty (USA), Corp. (603528605)