Your browser does not support JavaScript! PLANET SUN SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SHINE & PRETTY (USA), CORP.]
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PLANET SUN SPF 30 (octinoxate, zinc oxide) lotion
[Shine & Pretty (USA), Corp.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active Ingredients

Octinoxate, 7.5% (UVB sunscreen), Zinc oxide, 10.0% (UVA/UVB sunscreen)

Warnings

For external use only, not to be swallowed. Avoid contact with eye. Discontinue if signs of irritation or rash appear.

Purpose

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.

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.

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).

Questions?

(805) 388-8581

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.

Principal Panel Display

MM1

Label Graphic

PLANET SUN SPF 30 
octinoxate, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59663-120
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
VITAMIN A PALMITATE 
CHAMOMILE 
CUCUMBER 
ETHYLHEXYL PALMITATE 
CYCLOMETHICONE 
BUTYLENE GLYCOL 
.ALPHA.-TOCOPHEROL ACETATE 
SODIUM CHLORIDE 
KUKUI NUT 
CAMELLIA OLEIFERA SEED 
ALOE VERA LEAF 
TETRAHEXYLDECYL ASCORBATE 
ALLANTOIN 
SODIUM PYRROLIDONE CARBOXYLATE 
EDETATE DISODIUM 
ETHYLHEXYLGLYCERIN 
METHYLISOTHIAZOLINONE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59663-120-04120 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2013
Labeler - Shine & Pretty (USA), Corp. (603528605)

Revised: 7/2013
 
Shine & Pretty (USA), Corp.

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